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Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01597765
Collaborator
ChaingMai University (Other)
60
Enrollment
1
Location
2
Arms
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
  • Drug: Curcuminoids and alpha-tocopherol
 N/A

Detailed Description

60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Curcuminoids

The administrate curcuminoids is intervention for 30 patients

Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
Other Names:
  • curcuminoids 500 mg brand name Anti-Ox
  • N-acetylcysteine 200 mg brand name Mysoven
  • deferiprone 50 mg/kg/day brand name GPO-L-ONE
  • vitamin E 400 IU/day brand name Natural

    • Drug: Curcuminoids and alpha-tocopherol
    group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day
    Experimental: Vitamin E

    The vitamin E is intervention for 30 patients

    Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
    receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
    Other Names:
  • curcuminoids 500 mg brand name Anti-Ox
  • N-acetylcysteine 200 mg brand name Mysoven
  • deferiprone 50 mg/kg/day brand name GPO-L-ONE
  • vitamin E 400 IU/day brand name Natural

    • Drug: Curcuminoids and alpha-tocopherol
    group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day

    Outcome Measures

    Primary Outcome Measures

    1. Malonyldiadehyde (MDA) [1 year after treatment with antioxidant cocktail.]

      Lipid peroxidation will be assayed by measuring the formation of malonyldialdehyde (MDA). The formation of MDA on red blood cell will be exposed by hydrogen peroxide. Then, MDA will be extracted by trichloroacetic acid (TCA) and will be reacted with thiobarbituric acid (TBA) in boiling condition to MDA-TBAR complex. This complex will be given pink color and measuring at 532 and 600 nm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. age between 18-50 years

    2. hemoglobin level between 6-9 g/dL during screen visit

    3. WHO performance status grade 0-2

    4. signed in informed consents prior to the study entry.

    Exclusion Criteria:

    1. receiving iron chelator and blood transfusion.

    2. pregnancy or breastfeeding

    3. receiving other drugs except folic acid at least 30 days before study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University
    • ChaingMai University

    Investigators

    • Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr., Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01597765
    Other Study ID Numbers:
    • Si 063/2009
    First Posted:
    May 14, 2012
    Last Update Posted:
    May 15, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Mahidol University
    Thalassemia
    Oxidative stress
    antioxidant cocktail
    Additional relevant MeSH terms:
    Thalassemia
    beta-Thalassemia
    Vitamins
    Vitamin E
    Tocopherols
    Tocotrienols
    alpha-Tocopherol
    Acetylcysteine
    N-monoacetylcystine
    Deferiprone

    Study Results

    No Results Posted as of May 15, 2012